This is going to be a busy rulemaking season for the government and healthcare technology developers. The Unified Agenda, a summary of all coming proposed and final rules from the Department of Health and Human Services (“DHHS”), shows a flurry of activity that health IT developers should be alert to. Please note, all dates are subject to change.
- This month, the Office of the Inspector General should finalize its civil monetary penalties for information blocking. The proposed fines are the same as the statutory cap: $1,000,000 per violation. The OIG noted that in FY 2021 it had a budget of $5.3 million to investigate information blocking.
- In July 2022, we should see a proposed update the 21st Century Cures Act regulations. In addition to updating the information blocking regulations, this proposal will introduce new certification standards related to real time benefit tools and prior authorization. It will also touch on the Trusted Exchange Framework and Common Agreement (“TEFCA”) and an attestation process that participants comply with it.
- This month, the Office of Civil Rights will issue a request for information asking for feedback on recognized security practices.
- CMS will propose the new Inpatient Prospective Payment Schedule (how hospitals get paid), Physician Payment Schedule (how doctor offices get paid), and changes to both Medicare Part C and D (private Medicare and Medicare drug coverage respectively), starting in the summer. These are important to watch. The IPPS may contain changes to the EHR Incentive Program/meaningful use penalty for hospitals – which is incurred if they don’t use their technology enough. the Merit-Based Incentive Payment System does the same on the physician practice side. Part C and Part D regulations are a common place to see changes to e-prescribing and other technical standards.
Keep an eye out. You can find the full list of proposed rules for DHHS below:
eHealth Law Blog 